MAUDE Adverse Event Report: STERIS BIOLOGICAL OPERATIONS VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR

Device Problem False Positive Result (1227)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/08/2015

Event Type  No Answer Provided  

Event Description

The user facility reported they obtained positive bi results.Instruments were not reprocessed prior to use in patient procedure.No report of procedural delay or cancellation.

Manufacturer Narrative

The user facility stated they obtained three positive verify scbi results following processing in 3rd party sterilizers.At the time of the event, the facility was performing a test trial of the steris verify v24 scbi, and as such, ran the scbi alongside another brand of 3rd party bis.The facility stated in three instances, the verify scbi evidenced positive results; however the 3rd party bi evidenced negative, passing results.In all instances, the sterilizer cycle printouts confirmed passing results; no cycle alarms or aborts were noted by facility staff.The facility did not recall or reprocess instruments subject of the positive verify scbi as the equipment was operating according to specification and the 3rd party bi evidenced passing results.The dhr of the lot number subject of the reported event was reviewed; no issues were noted.Additionally, retains of the lot were tested, and no issues were noted.The steris account manager for the facility stated the customer was not using the activator to crush the bis, which could have resulted in the positive bi results.The instructions for use state, "to seal and activate, place scbi into the specially designed cavity of the verify self-contained biological indicator hp activator handle." steris offered the facility in-service training on the proper handling of the scbi, however the facility declined.In addition, verify scbi instructions for use state, "the scbi is positive for growth if it demonstrates turbidity and/or a color change from orange to yellow.Conditions for sterilization were not achieved.Follow departmental procedures for reporting sterilization failures." the facility stated they have a procedure in place for notifying patients when a positive bi occurs, however, did not inform patients in this case as they ran the bis along with sterrad bis and cis which passed with no issues.Steris is submitting this mdr as the facility did not follow the verify scbi instructions for use and did not reprocess instruments after receiving positive bi results.

• Brand Name: VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR
• Type of Device: BIOLOGICAL INDICATOR
• Manufacturer (Section D): STERIS BIOLOGICAL OPERATIONS; 9325 pinecone dr; mentor OH 44060
• Manufacturer (Section G): STERIS BIOLOGICAL OPERATIONS; 9325 pinecone dr.; mentor OH 44060
• Manufacturer Contact: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 4753185
• MDR Text Key: 21795907
• Report Number: 3004080920-2015-00012
• Device Sequence Number: 1
• Product Code: FRC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/08/2015
• Initial Date FDA Received: 05/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other